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Production Technical Support Engineer I

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POST DATE 8/12/2016
END DATE 10/20/2016

Shire Pharmaceutical Lexington, MA

Company
Shire Pharmaceutical
Job Classification
Full Time
Company Ref #
14216BR
Location
Lexington, MA
Experience
Entry Level (0 - 2 years)
Job Type
Regular
AJE Ref #
575861683

JOB DESCRIPTION

Job Description
PRIMARY ROLE
The individual will be expected to monitor and provide support for manufacturing purification operations. Responsibilities will include attending manufacturing morning meeting, daily production data trend review, event response and troubleshooting, batch review, deviation initiation support and manufacturing personnel training. The individual will also be responsible for sampling and/or testing protocol authoring and review, as well as SOP and batch record review.

RESPONSIBILITIES
80% Floor Support Support ongoing operations on the manufacturing floor. Attend manufacturing morning meeting. Respond and troubleshoot process issues; evaluate process data including chromatography trends and column performance/integrity. Conduct batch review. Provide training to manufacturing personnel. Identify and advance continuous improvement initiatives. Provide inspection support as needed. Provide weekend call-in coverage as needed.

10% Process Quality Systems Support deviation initiation, conduct operator interview, and provide detailed event description.

10% Documentation Author testing/sampling protocol. Review SOP and batch record as needed.

EDUCATION & EXPERIENCE REQUIREMENTS
BS in Chemical/Biochemical Engineering or Bio/Chemistry with 1-3 years or MS with 0-2 years of process development / manufacturing experience for mammalian cell culture of recombinant proteins.

Hands-on experience with large-scale purification manufacturing processes, preferably with commercial or licensed products. A working familiarity with single use process systems, automation (local and distributed control systems), and sterile/aseptic processing in a cGMP environment. Knowledge of the science and technology for the major unit operations associated with manufacturing operations to include fluid transfer, filtration, chromatography, CIP/SIP, and UF/DF processes. Experience with troubleshooting / problem solving and risk assessment / mitigation. Demonstrated experience making science based and/or data-driven recommendations for manufacturing operations.

Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We have best-in-class products available in more than 100 countries across core therapeutic areas including Hematology, Immunology, Neuroscience, Lysosomal Storage Disorders, Gastrointestinal / Internal Medicine / Endocrine and Hereditary Angioedema; a growing franchise in Oncology; and an emerging, innovative pipeline in Ophthalmics.

Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.

EQUAL EMPLOYMENT OPPORTUNITY
Shire is an equal opportunity employer. Shire evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

EEO is the Law
EEO is the Law - Supplement
Pay Transparency Policy

Reasonable Accommodations
Shire is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.

Minimum Requirements
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